NarcolepsyNCT05709873
Narcolepsy Nightmare Study
A study testing Imagery rehearsal therapy in people with Narcolepsy and Narcolepsy Type 1, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this clinical trial is to test two behavioral treatments for nightmares in adults with narcolepsy. The main questions it aims to answer are: Is imagery rehearsal therapy (IRT) effective for narcolepsy-related nightmares? Does adding targeted dream control (TDC) to IRT make it more effective? Participants… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Narcolepsy, Narcolepsy Type 1, Narcolepsy With Cataplexy
- What is being tested?
- Imagery rehearsal therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of narcolepsy
- Age 18 or older
- Speak English
- Live in the United States
- Receiving standard medical care for narcolepsy
- Sleep and psychiatric medications stable for at least 3 months
Show all 10Show fewer
- Nightmare frequency of ≥3 times per week
- Nightmare Disorder Index score indicates probable nightmare disorder
- Able to attend a study appointment in Evanston, IL
- Able and willing to not take wake-promoting medications on day of lab visit
Who cannot join
- History of a neurological disorder that might alter EEG
- Currently engaged in sleep- or trauma-focused psychotherapy
- Previous behavioral treatment for nightmares
- Medical, psychiatric, or cognitive condition which would interfere with ability to engage in the treatment
- Untreated sleep apnea (AHI ≥ 5)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioral Treatment of Narcolepsy-Related Nightmares
The goal of this clinical trial is to test two behavioral treatments for nightmares in adults with narcolepsy. The main questions it aims to answer are:
- Is imagery rehearsal therapy (IRT) effective for narcolepsy-related nightmares?
- Does adding targeted dream control (TDC) to IRT make it more effective?
Participants will be randomized to one of two treatment groups and will be asked to:
- Complete a daily log of sleep symptoms for up to 13 weeks.
- Attend 7 sessions of treatment.
- Complete questionnaires before and after treatment.
- Go to the research lab in Evanston, IL to complete a sleep study during a daytime nap (Chicago area residents only).
- Conditions
- Narcolepsy, Narcolepsy Type 1, Narcolepsy With Cataplexy, Narcolepsy Type 2, Narcolepsy Without Cataplexy
- Being tested
- Imagery rehearsal therapy, Targeted dream control
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imagery rehearsal therapyBehavioural
Also called IRT
Therapy to reduce nightmares, delivered via videoconference sessions
Targeted dream controlBehavioural
Also called TDC
Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
| Study group | Role | What they receive |
|---|---|---|
| Imagery rehearsal therapy (IRT) | Experimental | Participants randomized to this group will receive 7 sessions of IRT. Receives: Behavioral: Imagery rehearsal therapy |
| Imagery rehearsal therapy and targeted dream control (IRT+TDC) | Experimental | Participants randomized to this group will receive 7 sessions of IRT+TDC. Receives: Behavioral: Imagery rehearsal therapy; Behavioral: Targeted dream control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nightmare Frequency
Frequency of nightmares as measured by daily diary
Measured: Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)
Disturbing Dream and Nightmare Severity Scale
Measures nightmare severity. Minimum = 0, maximum = 37. Higher scores represent a worse severity of nightmares.
Measured: Baseline and posttreatment (up to 13 weeks)
Secondary outcomes (2)
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
Measures symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more anxiety symptoms (worse outcome). Population mean (T-score) of 50 with a standard deviation of 10.
Measured: Baseline and posttreatment (up to 13 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale
Measures symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more depressive symptoms (worse outcome). Population mean (T-score) of 50 with a standard deviation of 10.
Measured: Baseline and posttreatment (up to 13 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start22 Feb 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Mundt, PhD, Northwestern University
- Investigators
- Jennifer Mundt, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709873
- Sponsor's protocol ID
- STU00218129
- Status last verified
- Apr 2026
- First submitted
- 24 Jan 2023
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Treatment of Narcolepsy-Related Nightmares
- ClinicalTrials.gov ID
- NCT05709873
- Acronym / sponsor ID
- STU00218129
- Conditions
- Narcolepsy, Narcolepsy Type 1, Narcolepsy With Cataplexy, Narcolepsy Type 2, Narcolepsy Without Cataplexy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test two behavioral treatments for nightmares in adults with narcolepsy. The main questions it aims to answer are:
- Is imagery rehearsal therapy (IRT) effective for narcolepsy-related nightmares?
- Does adding targeted dream control (TDC) to IRT make it more effective?
Participants will be randomized to one of two treatment groups and will be asked to:
- Complete a daily log of sleep symptoms for up to 13 weeks.
- Attend 7 sessions of treatment.
- Complete questionnaires before and after treatment.
- Go to the research lab in Evanston, IL to complete a sleep study during a daytime nap (Chicago area residents only).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imagery rehearsal therapy (IRT) | Experimental | Behavioral: Imagery rehearsal therapyParticipants randomized to this group will receive 7 sessions of IRT. |
| Imagery rehearsal therapy and targeted dream control (IRT+TDC) | Experimental | Behavioral: Imagery rehearsal therapy, Behavioral: Targeted dream controlParticipants randomized to this group will receive 7 sessions of IRT+TDC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of narcolepsy
- Age 18 or older
- Speak English
- Live in the United States
- Receiving standard medical care for narcolepsy
Key exclusion criteria (5 listed)
- History of a neurological disorder that might alter EEG
- Currently engaged in sleep- or trauma-focused psychotherapy
- Previous behavioral treatment for nightmares
- Medical, psychiatric, or cognitive condition which would interfere with ability to engage in the treatment
- Untreated sleep apnea (AHI ≥ 5)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imagery rehearsal therapyAlso: IRTTherapy to reduce nightmares, delivered via videoconference sessions | Behavioural | Imagery rehearsal therapy (IRT), Imagery rehearsal therapy and targeted dream control (IRT+TDC) |
| Targeted dream controlAlso: TDCTherapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap. | Behavioural | Imagery rehearsal therapy and targeted dream control (IRT+TDC) |
Primary outcome
Nightmare Frequency
Time frame: Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)
Frequency of nightmares as measured by daily diary
Disturbing Dream and Nightmare Severity Scale
Time frame: Baseline and posttreatment (up to 13 weeks)
Measures nightmare severity. Minimum = 0, maximum = 37. Higher scores represent a worse severity of nightmares.
2 secondary outcomes
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
Time frame: Baseline and posttreatment (up to 13 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale
Time frame: Baseline and posttreatment (up to 13 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Mundt, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imagery rehearsal therapy in people with Narcolepsy and Narcolepsy Type 1, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nightmare Frequency (time frame: Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.